Proposal would disincentivize life-saving medical innovation
Washington – This week, Congressman Darrell Issa (CA-48), Chairman of the House Judiciary Subcommittee on Courts, Intellectual Property, and the Internet, co-led a letter to President Biden opposing the administration’s plan to utilize march-in rights provisions of the Bayh-Dole Act to regulate drug prices.
The proposal, issued by the National Institute of Standards and Technology (NIST), would allow the government to “march in” and take intellectual property protections from innovators if certain price conditions are met. This proposal will undoubtedly harm California’s life sciences, threaten U.S. competitiveness, and curtail the pipeline of future patient health solutions.
An excerpt from the letter:
“That leaves only the serious unintended consequences of NIST’s draft framework, which would apply to all types of technologies and products, not just pharmaceuticals. Under the proposed framework, entrepreneurial startups and small companies across industries—from green technology and precision agriculture to advanced computing and semiconductors—would be subject to march-in petitions challenging their pricing decisions by rival businesses and even our foreign competitors and adversaries, who could use this tool to cast a cloud over the companies that drive our economy. The increased risk of losing control over critical patents also threatens to deter the private investment necessary to commercialize products incorporating federally funded research, preventing the public from benefiting from that research. The result would be to reverse the very advances the Bayh-Dole Act has achieved, and to disastrously disincentivize innovation.
“American innovation is the envy of the world thanks in large part to the Bayh-Dole Act. The proposed NIST guidance attempts to change this landmark legislation’s long-established meaning without the consent of Congress. Such an action undermines the separation of powers enshrined in our constitutional system—all without even accomplishing its intended purpose of lowering drug prices. The draft framework will hamstring U.S. innovation to the advantage of our competitors and adversaries, and thus, we urge you to reconsider the NIST proposal.”
Co-authors of the letter include Senator Chris Coons (D-DE), Senator Thom Tillis (R-NC), and Congressman Jake Auchincloss (MA-04).
California is home to approximately 1700 life science companies whose work could be impacted by this proposal.
The full letter can be found here.
Darrell Issa is the Representative of California’s 48th Congressional District. The District encompasses the central and eastern parts of San Diego County and a portion of Riverside County, including the communities of Fallbrook, Valley Center, Ramona, Escondido, Santee, Lakeside, Poway, Temecula, Murrieta, and the mountain and desert areas of the San Diego-Imperial County line. Issa served as the Chairman of the House Committee on Oversight and Government Reform from 2011-2015.
